Lengthening Temporalis Myoplasty and Improvement of Primary Swallowing Disorders in Facial Paralysis

NCT03284125 | Completed

• 3 other identifiers: RIPH3-RNI17/MATPF2017-A01577-462017-39
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The facial paralysis is a frequent disease causing important functionals swallowing dysfunctions. The purpose of our study was to evaluate the improvement of the swallowing disorders after surgery by lengthening temporalis myoplasty (LTM) in the facial paralysis. This prospective study has realised on the following of patients affected by facial paralysis treated by LTM. Self-administered questionnaires and clinics tests had realized to analyze three components oh the oral phase of the swallowing ( drooling, mastication and handicap). The evaluations was realized before the surgery and at 3 and 6 months after .

Conditions

Peripheral Facial Paralysis

Outcome Measures

Primary Outcomes (1)

• Change from baseline lips pressure at 6 months

  Patients must contracted their lips of the paretic side in a manometer to evaluate the pressure of the lips before surgery and at 3 and 6 months after

  Baseline, 3 and 6 months

Secondary Outcomes (3)

• Drooling Severity and Frequency Scale (DSFS)

  Baseline, 3 and 6 months

• Visual scale of food residue

  Baseline, 3 and 6 months

• Dysphagia handicap index (DHI)

  Baseline, 3 and 6 months

Study Arms (1)

Facial paralysis

Patients affected by facial paralysis treated by LTM The aim is to evaluate the improvement of the swallowing disorders after surgery.

Other: Swallowing disorders evaluation

Interventions

Swallowing disorders evaluation OTHER

Self-administered questionnaires and non-invasive clinics tests

Facial paralysis

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients affected by facial paralysis and treated by lenthening temporalis myoplasty

You may qualify if:

• Chronic peripheral facial paralysis
• Freyss score inferior at 15
• Benefiting of a lengthening temporalis myoplasty

You may not qualify if:

• Malformative syndrome
• Other swallowing trouble
• Psychiatric trouble
• Opposed at this study

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

Service de chirurgie maxillo-faciale, CHRU de TOURS

Tours, 37044, France

Location

MeSH Terms

Conditions

Facial Paralysis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Boris LAURE, MD-PhD

  University Hospital, Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 15, 2017
• Study Start: September 2, 2017
• Primary Completion: June 12, 2018
• Study Completion: June 12, 2018
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)